Composite container

ABSTRACT

There is disclosed composite container comprising a thermally insulated inner container disposed within a thermally insulated outer container. The thermally insulated inner container is configured to receive one or more phase change material (PCM) elements to define a payload enclosure. The one or more PCM elements are configured to maintain a payload disposed in the payload enclosure initially at −20° C. between 8° C. and −25° C., such as between 2° C. and 8° C. or between −15° C. and −25° C., for a period of at least 48 hours in an ambient temperature of up to 35° C. when tested pursuant to ISTA 7D Test Procedure. The composite container can be used to ship temperature-sensitive payloads such as perishable goods (e.g., a COVID-19 vaccine such as the Moderna COVID-19 vaccine).

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority of Canadian (CA) Patent Application No.3,111,955, filed on Mar. 12, 2021, which are hereby incorporated hereinby reference in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to reusable composite containers. Inparticular, the present invention relates to reusable compositecontainers for cold chain packaging. Other aspects of the invention willbecome apparent to those of skill in the art upon reviewing the presentspecification.

Description of the Prior Art

Cold chain packaging allows temperature control of a payload (e.g.,perishable goods) during shipping and distribution of a package.Containers used for cold chain packaging may be composed of a variety ofmaterials including expanded polystyrene (EPS). EPS is thermallyinsulating and lightweight but easily damaged. Forces exerted upon anEPS container during shipping and handling can result in damage to thecontainer as well as the payload housed inside. Further, when an EPScontainer harbouring a temperature-sensitive payload is damaged, thecontainer must be opened and the payload transferred to a new container,which subjects the payload to potentially harmful temperaturefluctuations. The relative fragility of EPS also leads many packagerecipients to consider EPS containers as single-use containers,resulting in their mass disposal and waste.

Senders and recipients of temperature-sensitive goods may desireimproved thermal insulation over that provided by EPS alone. This isparticularly important for perishable goods where even small temperaturevariations can impair the activity of the product (e.g.,pharmaceuticals) or reduce its shelf-life (e.g., seafood).

In March 2020, a global pandemic was declared due to the now well-knownoutbreak of Covid-19. Later in 2020, both Pfizer-BioNTech and Modernadeveloped vaccines for Covid-19 and these vaccines began to receiveregulatory approval by various countries toward the end of 2020.

These initially approved vaccines must be stored at very coldtemperatures (e.g., −80° C.) to maintain their viability and efficacy.

According to the Province of Ontario Ministry of Health guidelines, therecommended storage temperature of the Pfizer-BioNTech COVID-19 vaccineis −70° C. while the recommended storage temperature of the ModernCOVID-19 vaccine is −20° C.(http://www.health.gov.on.ca/en/pro/programs/publichealth/coronavirus/docs/vaccine/vaccine_storage_handling_pfizer_moderna_pdf).These guidelines further state that, in the case of the Moderna vaccine,if placed in a portable freezer unit (−25° C. to −15° C.), the vaccinescan go back into a freezer unit after they are received at theirdestination.

It would be desirable to a container capable of maintaining a payloaddisposed in the payload enclosure between −15° C. and −25° C. for aperiod of at least 48 hours in an ambient temperature of up to 35° C.when tested pursuant to ISTA 7D Test Procedure.

SUMMARY OF THE INVENTION

It is an object of the present invention to obviate or mitigate at leastone of the above-mentioned disadvantages of the prior art.

Accordingly, the present invention relates to a composite containercomprising a thermally insulated inner container disposed within athermally insulated outer container, the thermally insulated innercontainer configured to receive one or more phase change material (PCM)elements to define a payload enclosure, the one or more PCM elementsconfigured to maintain a payload disposed in the payload enclosureinitially at −20° C. between 8° C. and −25° C., such as between 2° C.and 8° C. or between −15° C. and −25° C., for a period of at least 48hours in an ambient temperature of up to 35° C. when tested pursuant toISTA 7D Test Procedure.

As is known in the art, International Safe Transit Association (ISTA) 7DTest Procedure is a development test to evaluate the effects of externaltemperature exposures of individual packaged-products. The following aresome features in overview of the ISTA 7D Test Procedure:

-   -   it can be used for the development of temperature controlled        transport packages made of any material;    -   it can be used for individual or comparative performance        analysis of standard or insulated transport packages against        normally encountered conditions;    -   it is designed to measure the relative ability of a package to        protect a product when exposed to test cycles of temperature        conditions;    -   the product (payload) and package are considered together and        not separately; and    -   it is intended to evaluate the protection afforded        packaged-products from shock, vibration and/or compression (see        later—re. ISTA 3A Test Procedure).        The details of conducting Test Procedure 7A are available from        ISTA.

The composite container may be used to ship perishable goods, and duringshipping, the perishable goods may be maintained at a nearly constanttemperature below the ambient temperature using cooling means. Thecontainer may be shipped by a sending party and received by a receivingparty, and the receiving party may return the container to the sendingparty after receiving the container. The sending party may then reusethe container to ship perishable goods.

The present composite container is well suited transport a COVID-19vaccine such as the Moderna vaccine.

In a preferred embodiment the present composite container furthercomprises a Radio Frequency Identification (RFID) element (e.g., in theform of a tag, sticker, etc.) allowing the user to identify,authenticate, track, sense and engage with each item relativelyseamlessly. Further details on suitable RFID elements can be found athttps://rfid.averydennison.com/en/home/explore-rfid/for-brands-and-enterprise-customers.html.

If the RFID element is used with the present composite container, it maybe preferably placed on one or two, more preferably, two interiorsurfaces of the inner container. Alternatively, the RFID element couldbe placed on one or two, more preferably, two exterior surfaces of theinner container. Alternatively, one RFID element could be placed on aninterior surface of the inner container and one RFID element could beplaced on an exterior surface of the inner container.

If the RFID element is used with the present composite container, it maybe preferably placed on one or two, more preferably, two interiorsurfaces of the outer container. Alternatively, the RFID element couldbe placed on one or two, more preferably, two exterior surfaces of theouter container. Alternatively, one RFID element could be placed on aninterior surface of the outer container and one RFID element could beplaced on an exterior surface of the outer container.

If the RFID element is used with the present composite container, it ispreferred to use two RFID elements, more preferably one RFID element onthe container lid (inner container or outer container) and one RFIDelement on the container receptacle (inner container or outercontainer).

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present invention will be described with reference tothe accompanying drawings, wherein like reference numerals denote likeparts, and in which:

FIG. 1 is a perspective exploded view of a preferred embodiment of thepresent composite container; and

FIGS. 2A-2B and 3A-3B illustrate the result of testing preferredversions of the composite container illustrated in FIG. 1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention relates to a composite container comprising athermally insulated inner container disposed within a thermallyinsulated outer container, the thermally insulated inner containerconfigured to receive one or more phase change material (PCM) elementsto define a payload enclosure, the one or more PCM elements configuredto maintain a payload disposed in the payload enclosure initially at−20° C. between 8° C. and −25° C., such as between 2° C. and 8° C. orbetween −15° C. and −25° C., for a period of at least 48 hours in anambient temperature of up to 35° C. when tested pursuant to ISTA 7D TestProcedure. Preferred embodiments of the present composite container mayinclude any one or a combination of any two or more of any of thefollowing:

-   -   one or both of the thermally insulated inner container and the        thermally insulated outer container are made from a foam        material;    -   the foam material is selected from the group consisting of        expanded polypropylene (EPP), expanded polystyrene (EPS),        expanded polyethylene (EPE), porous EPP and expanded PS/PE;    -   the thermally insulated inner container is made from EPS and the        thermally insulated outer container is made from a different        foam;    -   the thermally insulated inner container is made from EPS and the        thermally insulated outer container is made from EPP;    -   the foam material has a density of at least about 1.5 pcf;    -   the foam material has a density of at least about 1.6 pcf;    -   the foam material has a density of at least about 1.7 pcf;    -   the foam material has a density of at least about 1.75 pcf;    -   the inner container is separable from the outer container;    -   at least one of the inner container and the outer container is        integral;    -   the inner container comprises a an inner container lid element        removably coupled to an inner container receptacle element.    -   the inner container is shaped as a cube or rectangular cuboid;    -   outer container comprises a an outer container lid element        removably coupled to an container receptacle element;    -   outer container is shaped as a cube or rectangular cuboid;    -   the one or more phase change material (PCM) elements are        configured to be pre-conditioned to a temperature of at least        about −25° C.;    -   the one or more phase change material (PCM) elements are        configured to be pre-conditioned to a temperature of at least        about −30° C.;    -   the composite container comprising a plurality of phase change        material (PCM) elements combining to define the payload        enclosure;    -   a first phase change material (PCM) element is configured to be        in abutting relationship with a second phase change material        (PCM);    -   a first phase change material (PCM) element is configured to be        in a detachably coupled relationship with a second phase change        material (PCM); and/or    -   the phase change material (PCM) element comprises a rigid        container have disposed therein a gel material.

The present composite may be used to transport payload disposed in thepayload enclosure from a shipping location to a destination location.The payload maybe a perishable product, preferably a pharmaceuticalproduct, preferably a vaccine product such as product such as COVID-19vaccine product (e.g., the Moderna vaccine described above).

The present composite container comprises a thermally insulated innercontainer disposed within a thermally insulated outer container.Preferably, one or both, more preferably both, of the thermallyinsulated inner container disposed and the thermally insulated outercontainer are made of foam.

Some details of preferred embodiments of the present composite containermay be found in International Publication Number WO2016/008057A1.

In a preferred embodiment, the present composite container is configuredto comply with ISTA 3A Test Procedure.

As is known in the art, Test Procedure 3A is a general simulation testfor individual packaged-products shipped through a parcel deliverysystem. The test is appropriate for four different package typescommonly distributed as individual packages, either by air or ground.The types include standard, small, flat and elongated packages. BasicRequirements: atmospheric pre-conditioning, random vibration with andwithout top load, and shock testing. The details of conducting TestProcedure 3A are available from ISTA.

The phase change material (PCM) element is generally known. A PCM willmaintain the temperature of the payload at its stated phase changetemperature while undergoing its solid/liquid phase transitions. A PCMwill respond to the outside environmental temperature by absorbing orreleasing heat as it changes state from solid to liquid and back. Theprocess is reversible and repeatable while always maintaining the sametemperature.

Preferably, the phase change material (PCM) element useful in thepresent composite container is in the form of a rigid containercomprising a cooling gel. In a preferred embodiment, the rigidhigh-density polyethylene (HDPE) plastic container is sealed to preventleakage and offers excellent resistance to compression and breakage.Durability also means the product is capable of being cleaned andrefrozen for repeated use. It does not change shape when thawed orfrozen, helping to prevent contents from shifting.

A preferred phase change material (PCM) element useful in the presentcomposite container is commercially available from Rapid Aid under thetradename Temp Aid™.

With reference to FIG. 1, there a perspective exploded view of apreferred embodiment of the present composite container. In a first morepreferred embodiment, the phase change material (PCM) elements arespecified at −20° C. In a first more preferred embodiment, the phasechange material (PCM) elements are specified at 5° C.

The product changes phase at the specified temperature to provideoptimal thermal protection. When the adjacent temperature dips below thephase change temperature, the gel will solidify and release its storedenergy. If the surrounding temperature goes above the phase changetemperature, it will liquefy and absorb the excess energy.

The a composite container in accordance with the first more preferredembodiment was tested with a simulated payload (a compartmentalizedwater blanket modified to include three (3) thermocouples to measure thetemperature at the top, middle and bottom of the simulated payload),together with a temperature probe in the product itself. This compositecontainer was subjected to the ISTA 7D Test Procedure.

The results of the ISTA 7D Test Procedure are illustrated in FIG. 2a(ambient conditions) and FIG. 2b (payload temperature). As shown in thecombination of FIGS. 2a and 2b , the composite container in accordancewith the first more preferred embodiment was able to maintain thetemperature of the top, middle and bottom of the payload deposited at−20° C. between −15° C. and −25° C. for least 48 hours when thecomposite container was placed in ambient conditions ranging from 22° C.to 35° C.

The a composite container in accordance with the second more preferredembodiment was tested with a simulated payload (a compartmentalizedwater blanket modified to include three (3) thermocouples to measure thetemperature at the top, middle and bottom of the simulated payload),together with a temperature probe in the product itself. This compositecontainer was subjected to the ISTA 7D Test Procedure.

The results of the ISTA 7D Test Procedure are illustrated in FIG. 3a(ambient conditions) and FIG. 3b (payload temperature). As shown in thecombination of FIGS. 3a and 3b , the composite container in accordancewith the second more preferred embodiment was able to maintain thetemperature of the top, middle and bottom of the payload deposited at 5°C. between 2° C. and 8° C. for least 48 hours when the compositecontainer was placed in ambient conditions ranging from 22° C. to 35° C.

The a composite container in accordance with the preferred embodimentillustrated in FIG. 1 was tested for ruggedness with a simulated payload(3.5 kg of sand split between two plastic bags). This compositecontainer was subjected to the ISTA 3A Test Procedure. Morespecifically, the packaged-product was subjected to each of thefollowing:

Atmospheric Pre-Conditioning 12 hrs Room Condition.

First Sequence Shock Test. Results: no puncture of package box(including inside the packaging) greater than 9 square inches or 10% ofthe damaged box surface, no failure of the tape or seal (include insidethe packaging) and no any parts escape the package box.

Random Vibration with Dynamic Load—Over the Road Trailer Simulation.Results: No abnormality was observed externally on the packaged-productand inside containers of EPP and EPS after completion.

Random Vibration without Load—Pick-up and Delivery Vehicle Simulation.Results: No abnormality was observed externally on the packaged-productand inside containers of EPP and EPS after completion

Second Sequence Shock Test. Results: no puncture of package box(including inside the packaging) greater than 9 square inches or 10% ofthe damaged box surface, no failure of the tape or seal (include insidethe packaging) and no any parts escape the package box.

In summary, the composite container in accordance with the preferredembodiment illustrated in FIG. 1 meet the requirements of the ISTA 3ATest Procedure.

While this invention has been described with reference to illustrativeembodiments and examples, the description is not intended to beconstrued in a limiting sense. Thus, various modifications of theillustrative embodiments, as well as other embodiments of the invention,will be apparent to persons skilled in the art upon reference to thisdescription. It is therefore contemplated that the appended claims willcover any such modifications or embodiments.

All publications, patents and patent applications referred to herein areincorporated by reference in their entirety to the same extent as ifeach individual publication, patent or patent application wasspecifically and individually indicated to be incorporated by referencein its entirety.

What is claimed is:
 1. A composite container comprising a thermallyinsulated inner container disposed within a thermally insulated outercontainer, the thermally insulated inner container configured to receiveone or more phase change material (PCM) elements to define a payloadenclosure, the one or more PCM elements configured to maintain a payloaddisposed in the payload enclosure initially at −20° C. between 8° C. and−25° C., such as between 2° C. and 8° C. or between −15° C. and −25° C.,for a period of at least 48 hours in an ambient temperature of up to 35°C. when tested pursuant to ISTA 7D Test Procedure.
 2. The container ofclaim 1, wherein one or both of the thermally insulated inner containerand the thermally insulated outer container are made from a foammaterial.
 3. The container of claim 2, wherein the foam material isselected from the group consisting of expanded polypropylene (EPP),expanded polystyrene (EPS), expanded polyethylene (EPE), porous EPP andexpanded PS/PE.
 4. The container of claim 2, wherein the thermallyinsulated inner container is made from EPS and the thermally insulatedouter container is made from a different foam.
 5. The container of claim2, wherein the thermally insulated inner container is made from EPS andthe thermally insulated outer container is made from EPP.
 6. Thecontainer of claim 2, wherein the foam material has a density of atleast about 1.5 pcf.
 7. The container of claim 1, wherein the innercontainer is separable from the outer container.
 8. The container ofclaim 1, wherein at least one of the inner container and the outercontainer is integral.
 9. The container of claim 1, wherein the innercontainer comprises an inner container lid element removably coupled toan inner container receptacle element.
 10. The container of claim 1,wherein the inner container is shaped as a cube or rectangular cuboid.11. The container of claim 1, wherein the outer container comprises a anouter container lid element removably coupled to an container receptacleelement
 12. The container of claim 1, wherein the outer container isshaped as a cube or rectangular cuboid.
 13. The container of claim 1,wherein the one or more phase change material (PCM) elements areconfigured to be pre-conditioned to a temperature of at least about −25°C.
 14. The container of claim 1, wherein one or more phase changematerial (PCM) elements are configured to be pre-conditioned to atemperature of at least about −30° C.
 15. The container of claim 1,comprising a plurality of phase change material (PCM) elements combiningto define the payload enclosure.
 16. The container of claim 15, whereina first phase change material (PCM) element is configured to be inabutting relationship with a second phase change material (PCM).
 17. Thecontainer of claim 15, wherein a first phase change material (PCM)element is configured to be in a detachably coupled relationship with asecond phase change material (PCM).
 18. The container of claim 1,wherein the phase change material (PCM) element comprises a rigidcontainer have disposed therein a gel material.
 19. The container ofclaim 1, wherein the container is configured to comply with ISTA 3A TestProcedure.
 20. The container of claim 1 wherein the container is used totransport payload disposed in the payload enclosure from a shippinglocation to a destination location.